FDA UDI
In Commercial Distribution
🇺🇸 United States
Abiomed Breethe OXY-1 System
DI: 00860001797909
·
Model: 001-0500-001
·
Breethe, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Abiomed Breethe OXY-1 System
- Primary DI
- 00860001797909
- Version / Model
- 001-0500-001
- Catalog Number
- 001-0500-001
- Company Name
- Breethe, Inc.
- Labeler DUNS
- 079455574
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-30
- Public Version
- 2
- Public Version Date
- 2023-05-19
- Public Version Status
- Update
- Public Device Record Key
- 0f78297b-e17b-46ef-a0da-2f3c9a4811f6
Device Description
OXY-1 System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | Cardiovascular | 870.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46838 | Cardiopulmonary bypass system, non-roller type | An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide features such as intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with centrifugal blood pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, and a defoamer. Some systems are manufactured as a single unit while others are made up of modules. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001797909 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223161 | 000 |